AnesthesiaPhase 4NCT05874245
Effect of Oral Dexmedetomidine, Ketamine, Or Midazolam as Preioperative Medications.
A Phase 4 study testing oral Dexmedetomidine, oral ketamine and oral Midazolam in people with Anesthesia, run by Menoufia University at 1 site in Egypt.
Trial summary
Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- oral Dexmedetomidine, oral ketamine and oral Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients within the age range of 3 to 8 years old.
- Elective non complicated adenotonsillectomy.
- ASA I or II physical status.
Who cannot join
- Refusal of the patient's parents or legal guardians to give informed consent.
- History of allergy to any of the study drugs.
- Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery.
- Neurological and/or psychological diseases.
- Associated cardio-respiratory illness
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia university hospitails
Shibīn al Kawm, Menoufia, 32111
Ahmed Abosayar
About this study
Official title: PERIOPERATIVE EFFECTS OF ORAL DEXMEDETOMIDINE, KETAMINE, OR MIDAZOLAM PREMEDICATION IN CHILDREN UNDERGOING ADENOTONSILLECTOMY
Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.
In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.
Read more
Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.
An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents. [5]
Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.
Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, antiemesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.
Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.
An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication.
Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.
Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.
Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.
Read the detailed description
Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.
In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.
Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.
An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents.
Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.
Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, anti-emesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.
Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.
An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication. Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.
Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.
Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.
- Conditions
- Anesthesia
- Being tested
- oral Dexmedetomidine, oral ketamine, oral Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral DexmedetomidineDrug
will receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia
oral ketamineDrug
will receive 6 mg/kg oral ketamine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia
oral MidazolamDrug
will receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group D; oral Dexmedetomidine | Experimental | will receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia. Receives: Drug: oral Dexmedetomidine |
| Group K; oral ketamine group | Experimental | will receive 6 mg/kg oral Ketamine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia. Receives: Drug: oral ketamine |
| Group M; oral Midazolam group | Experimental | will receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia. Receives: Drug: oral Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.
measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.
Measured: 12 months
Secondary outcomes (2)
Amount of analgesia required postperative by Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Pain Scale.
Amount of analgesia required postperative (Analgesia is maintained using diclofenac 1 mg/kg suppository. If 7-10 severe discomfort pain in the FLACC behavioral pain scale is heard, pethidine 1mg/kg/dose once, will be administered for persistent score in the 12-hour postoperative period.) according to Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Pain Scale
Measured: 12 months
Measure Emergence agitation by Richmond Agitation-Sedation Scale (RASS)
Measure Emergence agitation during recovery using Emergence agitation and recovery profile will be evaluated using the Richmond Agitation-Sedation Scale (RASS) to evaluate the patients' recovery profile.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a prospective randomized double-blind study. Patients will be randomized into three groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened by an anesthesiologist not involved in the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed elsayed mahmoud abousayar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874245
- Sponsor's protocol ID
- 11\2022 ANES 15
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERIOPERATIVE EFFECTS OF ORAL DEXMEDETOMIDINE, KETAMINE, OR MIDAZOLAM PREMEDICATION IN CHILDREN UNDERGOING ADENOTONSILLECTOMY
- ClinicalTrials.gov ID
- NCT05874245
- Acronym / sponsor ID
- 11\2022 ANES 15
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.
In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.
Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.
An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents. [5]
Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.
Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, antiemesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.
Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.
An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication.
Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.
Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.
Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.
Detailed description
Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.
In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.
Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.
An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents.
Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.
Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, anti-emesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.
Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.
An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication. Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.
Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.
Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study will be a prospective randomized double-blind study. Patients will be randomized into three groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened by an anesthesiologist not involved in the study
| Arm | Type | Receives |
|---|---|---|
| Group D; oral Dexmedetomidine | Experimental | Drug: oral Dexmedetomidinewill receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia. |
| Group K; oral ketamine group | Experimental | Drug: oral ketaminewill receive 6 mg/kg oral Ketamine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia. |
| Group M; oral Midazolam group | Experimental | Drug: oral Midazolamwill receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All patients within the age range of 3 to 8 years old.
- Elective non complicated adenotonsillectomy.
- ASA I or II physical status.
Key exclusion criteria (5 listed)
- Refusal of the patient's parents or legal guardians to give informed consent.
- History of allergy to any of the study drugs.
- Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery.
- Neurological and/or psychological diseases.
- Associated cardio-respiratory illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral Dexmedetomidinewill receive 4 micrograms/kg oral Dexmedetomidine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia | Drug | Group D; oral Dexmedetomidine |
| oral ketaminewill receive 6 mg/kg oral ketamine diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg 45 minutes before the induction of anaesthesia | Drug | Group K; oral ketamine group |
| oral Midazolamwill receive 0.3 mg/kg (maximum 20 mg) oral Midazolam diluted in paracetamol [Paracetamol syrup 150 mg/5ml] at a dose of 15 mg/kg given 45 minutes before the induction of anaesthesia | Drug | Group M; oral Midazolam group |
Primary outcome
measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.
Time frame: 12 months
measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.
2 secondary outcomes
Amount of analgesia required postperative by Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Pain Scale.
Time frame: 12 months
Measure Emergence agitation by Richmond Agitation-Sedation Scale (RASS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral Dexmedetomidine, oral ketamine and oral Midazolam in people with Anesthesia, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abosayar, Assisstant lecturer (+201064070141, Aabosayar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.